EP4349285A1 - Cathéter à ballonnet pour la segmentation linéaire d'un tissu glandulaire - Google Patents

Cathéter à ballonnet pour la segmentation linéaire d'un tissu glandulaire Download PDF

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Publication number
EP4349285A1
EP4349285A1 EP22815175.9A EP22815175A EP4349285A1 EP 4349285 A1 EP4349285 A1 EP 4349285A1 EP 22815175 A EP22815175 A EP 22815175A EP 4349285 A1 EP4349285 A1 EP 4349285A1
Authority
EP
European Patent Office
Prior art keywords
linear segmentation
balloon
balloon body
gasket
gland tissue
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP22815175.9A
Other languages
German (de)
English (en)
Inventor
Yan Wei
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Qingdao Biotech Medical Co Ltd
Original Assignee
Qingdao Biotech Medical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Qingdao Biotech Medical Co Ltd filed Critical Qingdao Biotech Medical Co Ltd
Publication of EP4349285A1 publication Critical patent/EP4349285A1/fr
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3209—Incision instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00274—Prostate operation, e.g. prostatectomy, turp, bhp treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22061—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation for spreading elements apart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3209—Incision instruments
    • A61B2017/32096—Incision instruments for slowly cutting through tissue, e.g. stent like temporary implants having sharp edges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/109—Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow

Definitions

  • the present disclosure relates to the field of medical instruments, in particular to a balloon catheter for linear segmentation of gland tissue.
  • the cutting balloon is to cut an atherosclerotic plaque on an inner wall of a blood vessel via balloon dilatation, by using a micro-blade carried on a surface of a balloon, and for a narrow blood vessel with sclerotic plaque which cannot be dilated by a common balloon, the cutting balloon usually can obtain a better effect by performing incisions on atherosclerotic plaques on the inner walls of blood vessels through balloon angioplasty.
  • the principle of the cutting balloon is, during balloon dilation, to cut a blood vessel wall having a sclerotic plaque by concentrating an expansion stress on a blade on a surface of a balloon, so that a diseased blood vessel can be dilated without a need of applying an extreme dilating pressure to the balloon.
  • a process of balloon dilation on a blood vessel is irregular, thus with the increase of a balloon dilation pressure, a damage rate of the balloon dilation on a blood vessel wall will increase, hence the cutting balloon requires a smaller dilating pressure than a conventional balloon, so as to produce a better dilating effect on a vascular disease and obtain better clinical curative effect.
  • a glandular tissue contains a large number of fiber muscles, after dilatation of a hyperplastic narrow gland through a common balloon, the fiber muscles with a high density of the glandular tissue will produce large rebound, resulting in narrow "blockage" of a dilated space again, thus if dilation of a common balloon wants to achieve a better dilation effect, it is necessary to select a balloon having a larger size according to a gland hyperplasia volume, meanwhile an extreme dilating pressure must be applied on the gland through balloon dilation.
  • the purpose of the present disclosure is to provide a balloon catheter for linear segmentation of gland tissue, capable of performing effective linear segmentation of a hyperplastic gland without a need for an extreme dilating pressure, greatly reducing damage to a gland in a circumferential direction during dilation and compressive rebound after a hyperplastic gland tissue is dilated, realizing effective dilation of the hyperplastic gland, obtaining an ideal dilated cavity space, and greatly improving a surgical efficiency and a postoperative effect.
  • the present disclosure provides a balloon catheter for linear segmentation of gland tissue, comprising a balloon body, an elastic connector and a linear segmentation part, in which: a middle portion of the elastic connector is fixed on a surface of the balloon body, the linear segmentation part is provided in the middle portion of the elastic connector, two ends of the elastic connector are fixedly connected with two ends of the balloon body respectively, and a position between the middle portion of the elastic connector and an end portion of the elastic connector is separated from the balloon body.
  • the present disclosure provides a balloon catheter for linear segmentation of gland tissue, including a balloon body 1, an elastic connector 2 and a linear segmentation part 3, in which a middle portion of the elastic connector 2 is fixed on a surface of the balloon body 1, the linear segmentation part 3 is provided in the middle portion of the elastic connector 2, two ends of the elastic connector 2 are fixedly connected with two ends of the balloon body 1 respectively, and a position between the middle portion of the elastic connector 2 and an end portion of the elastic connector 2 is separated from the balloon body 1.
  • the balloon catheter for linear segmentation of gland tissue can produce a stable linear segmentation stress on the glandular tissue when the balloon body 1 is dilated, promote linear cracking of the glandular tissue at a stress concentration site without additionally increasing a pressure on the balloon body 1, thereby to produce an ideal dilation effect and obtain an ideal dilated cavity space; during the use of the balloon catheter for linear segmentation of gland tissue, can avoid random tearing injury of the glandular tissue in a circumferential direction due to an irregular stress caused by high-pressure dilation 1 of the balloon body, thereby to obtain better clinical curative effect; providing an elastic connector 2 in the present disclosure can greatly improve stability of a connection between a highly rigid linear segmentation part 3 and the balloon body 1, effectively prevent displacement and falling of the linear segmentation part 3 due to glandular tissue extrusion during dilation of the balloon body 1, meanwhile can avoid occurrence of leakage of the balloon body 1 due to damage by the linear segmentation part 3 to the balloon body 1 during dilation of the balloon body 1.
  • a length of the elastic connector 2 in an axial direction of the balloon body 1 is less than an axial length under a contraction state of the balloon body 1.
  • a length of the elastic connector 2 in an axial direction of the balloon body 1 is less than an axial length by 0.5mm to 20mm under a contraction state of the balloon body 1.
  • the balloon body 1 includes a dilated straight working segment 101, two transition segments 102 and two thin-neck straight segments 103, the two transition segments 102 are respectively located on two sides of the extended straight working segment 101, one end of each of the two transition segments 102 are connected with two ends of the dilated straight working segment 101 respectively, and the other end of each of the two transition segments 102 are connected with corresponding thin-neck straight segments 103 respectively; in which a diameter of the dilated straight working segment 101 is greater than a diameter of the thin-neck straight segments 103, and a diameter of the transition segments 102 gradually decreases in a direction from the dilated straight working segment 101 to the thin-neck straight segments 103.
  • the balloon body 1 may be but is not limited to conical or cylindrical.
  • the balloon body 1 may also be a special-shaped columnar structure (such as: a dumbbell structure with a large diameter at both ends and a small diameter in the middle).
  • the dilated straight working segment 101, the transition segments 102 and the thin-neck straight segments 103 may be but are not limited to an integrally-formed structure.
  • the balloon body 1 i.e., the dilated straight working segment 101, the transition segments 102 and the thin-neck straight segments 103 is made of a high molecular material.
  • the balloon body 1 may be a single layer structure, the high molecular material used for the balloon body 1 having the single layer structure is any one of the group consisting of polyvinyl chloride, nylon, modified nylon and Pebax (a thermoplastic elastomer without containing a plasticizer); the balloon body 1 may also be a multilayered structure, the high molecular material used for the balloon body 1 having the multilayered structure is any one of the group consisting of polyvinyl chloride, nylon, modified nylon and Pebax.
  • the elastic connector 2 includes a gasket 201, two elastic tendons 202 and two sleeve rings 203, the gasket 201 is fixed on a surface of the dilated straight working segment 101, the two sleeve rings 203 are fixedly sleeved on the corresponding thin-neck straight segments 103 respectively, one of the elastic tendons 202 is connected between an end of the gasket 201 and one of the sleeve rings 203, and the other one of the elastic tendons 202 is connected between the other end of the gasket 201 and the other one of the sleeve rings 203, the two elastic tendons 202 are located respectively in a position axially opposite to the two transition segments 102 of the balloon body 1, and the two elastic tendons 202 are separated from the corresponding transition segments 102 so that the elastic connector 2 is in an active state.
  • the elastic tendons 202 When the balloon body 1 is in a contraction state, the elastic tendons 202 keep a horizontal contraction state consistent with the balloon body 1, so as to minimize a contraction size of the balloon body 1 and effectively improve the passage performance of the balloon body 1 in a narrow diseased position; when the balloon body 1 is in a dilation and swelling state, the elastic tendons 202 stretches to become longer with the dilation and swelling of the balloon body 1, so as to provide sufficient size guarantee for a deformation of the balloon body 1 during dilation and swelling.
  • a single linear segmentation part 3 assisted by dilation of the balloon body 1, can provide a stable linear segmentation stress to a glandular tissue, so that when the balloon body 1 is dilated, the glandular tissue cracks linearly at a stress concentration site, to effectively prevent displacement of the linear segmentation part 3 because the glandular tissue is extruded during dilation of the balloon body 1, thereby to avoid a failure of linear segmentation.
  • the single linear segmentation part 3 can ensure that a damage to the glandular tissue is minimized, and a single linear crack generated is conducive to rapid recovery of the glandular tissue after a surgery, so as to obtain the best clinical curative effect.
  • each elastic connector 2 is arranged in a circumferential direction of the balloon body 1, the middle portion of each elastic connector 2 is provided with the linear segmentation part 3.
  • the number of the elastic connectors 2 and a position in a circumferential direction of the balloon body 1 can be set according to an actual situation (such as a position where a glandular tissue needs to be partitioned) so as to meet the operational requirements.
  • the elastic connector 2 i.e., the gasket 201, the elastic tendons 202 and the sleeve rings 203 may be made of, but not limited to, plastic with viscoelasticity. Since the gasket 201 has excellent viscoelasticity, the balloon body 1 can serve as a stress buffer when being fully dilated, which can disperse a linear stress generated by the linear segmentation part 3 on a surface of the balloon body 1 and prevent a damage or leakage of the balloon body 1 caused by linear stress concentration. Moreover, since the gasket 201 has excellent viscoelasticity, the gasket 201 can be used as a bonding layer between the balloon body 1 and the hard linear segmentation part 3, which greatly improves the stability of fixing the linear segmentation part 3 on the surface of balloon body 1.
  • the plastic with viscoelasticity may be but is not limited to a polyurethane elastomer, rubber, silica gel, silicone rubber, polyether block polyamide, styrene-isoprene-styrol copolymer or polyolefin elastomer.
  • gasket 201 the elastic tendons 202 and the sleeve rings 203 may be but are not limited to an integrally-formed structure.
  • the gasket 201 has a long-strip shaped structure and extends along an axial direction of the balloon body 1, and a length of the gasket 201 is less than an axial length of the dilated straight working segment 101.
  • the sleeve ring 203 is a circular ring structure, an inner diameter of the sleeve ring 203 matches an outer diameter of the thin-neck straight segment 103, so that the sleeve ring 203 can be sleeved outside of the thin-neck straight segment 103 and is fixed connected with the thin-neck straight segment 103, which can improve the stability of the gasket 201 on the surface of the balloon body 1 during dilation and swelling of the balloon body 1.
  • the sleeve ring 203 when assembling the elastic connector 2 and the balloon body 1, the sleeve ring 203 may be sleeved directly the outside of the thin-neck straight segment 103 at both ends of the balloon body 1, and then the sleeve ring 203 and the thin-neck straight segment 103 are connected into one piece through a hot fusion processing mode.
  • the dilated straight working segment 101 of the balloon body 1 will produce an outward first stress on the gasket 201, the stress being perpendicular to the balloon body 1, the elastic tendons 202 is stretched to become longer with dilation and swelling of the balloon body 1, the sleeve ring 203 with two fixed ends applies a tension on the corresponding gasket 201 through the two elastic tendons 202 respectively, the tension will produce an inward second stress on the gasket 201 perpendicular to the balloon body 1, a direction of the second stress is opposite to that of the first stress, thus the stability of fixing the gasket 201 on the surface of the dilated straight working segment 101 during dilation of the balloon body 1 can be greatly improved.
  • a width of the gasket 201 is 0.3mm to 5mm, a thickness of the gasket 201 is 0.01mm to 2mm; and a width of the elastic tendons 202 is 0.15mm to 2.5mm.
  • the linear segmentation part 3 has a long-strip shaped structure, a length of the linear segmentation part 3 is less than a length of the gasket 201, a width of the linear segmentation part 3 is less than a width of the gasket 201, the linear segmentation part 3 is fixed in a middle position of a surface of the gasket 201, and the linear segmentation part 3 extends along a length direction of the gasket 201.
  • the linear segmentation part 3 may be formed through methods including but not limited to laser cutting, injection molding or 3D printing.
  • connection mode between the gasket 201 and the dilated straight working segment 101 of the balloon body 1 and the connection mode between the linear segmentation part 3 and the gasket may be but is not limited to thermal fusion, glue bonding or 3D printing.
  • a cross section of the linear segmentation part 3 is a polygon (such as a triangle, a diamond or a trapezoid), a distance from the top to the bottom of the cross section of the linear segmentation part 3 is 0.5mm to 5mm, and a width of a bottom of the cross section of the linear segmentation part 3 is less than 5mm.
  • the linear segmentation part 3 is made of a rigid-grade high molecular material or a metal material.
  • the high molecular material is PEEK (polyether-ether-ketone), HDPE (high density polyethylene), nylon, modified nylon or Pebax (a thermoplastic elastomer without containing a plasticizer);
  • the metal material is medical stainless steel, cobalt-base alloy, nickel-titanium alloy or titanium alloy.
  • a surface of the balloon body 1 and/or a surface of the linear segmentation part 3 is/are coated with a drug layer, so as to provide a targeted drug to a glandular tissue for treatment.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Child & Adolescent Psychology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
EP22815175.9A 2021-06-01 2022-05-27 Cathéter à ballonnet pour la segmentation linéaire d'un tissu glandulaire Pending EP4349285A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202110607643.2A CN113425380A (zh) 2021-06-01 2021-06-01 用于线性分割腺体组织的球囊导管
PCT/CN2022/095541 WO2022253129A1 (fr) 2021-06-01 2022-05-27 Cathéter à ballonnet pour la segmentation linéaire d'un tissu glandulaire

Publications (1)

Publication Number Publication Date
EP4349285A1 true EP4349285A1 (fr) 2024-04-10

Family

ID=77803447

Family Applications (1)

Application Number Title Priority Date Filing Date
EP22815175.9A Pending EP4349285A1 (fr) 2021-06-01 2022-05-27 Cathéter à ballonnet pour la segmentation linéaire d'un tissu glandulaire

Country Status (3)

Country Link
EP (1) EP4349285A1 (fr)
CN (1) CN113425380A (fr)
WO (1) WO2022253129A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113425380A (zh) * 2021-06-01 2021-09-24 青岛博泰医疗器械有限责任公司 用于线性分割腺体组织的球囊导管

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5797935A (en) * 1996-09-26 1998-08-25 Interventional Technologies Inc. Balloon activated forced concentrators for incising stenotic segments
US7153315B2 (en) * 2002-06-11 2006-12-26 Boston Scientific Scimed, Inc. Catheter balloon with ultrasonic microscalpel blades
US7754047B2 (en) * 2004-04-08 2010-07-13 Boston Scientific Scimed, Inc. Cutting balloon catheter and method for blade mounting
US7070576B2 (en) * 2004-04-30 2006-07-04 Boston Scientific Scimed, Inc. Directional cutting balloon
US20080300610A1 (en) * 2007-05-31 2008-12-04 Cook Incorporated Device for treating hardened lesions and method of use thereof
CN209122369U (zh) * 2018-05-18 2019-07-19 鼎科医疗技术（苏州）有限公司 一种切割球囊及球囊导管
CN112472228B (zh) * 2020-12-03 2022-05-06 广东博迈医疗科技股份有限公司 一种钙化斑块切割球囊
CN113425380A (zh) * 2021-06-01 2021-09-24 青岛博泰医疗器械有限责任公司 用于线性分割腺体组织的球囊导管

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Publication number Publication date
CN113425380A (zh) 2021-09-24
WO2022253129A1 (fr) 2022-12-08

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